A Study of Incidence of Musculoskeletal Disorders in Children Who Have Received Levofloxacin or a Standard Non-Fluoroquinolone Therapy for Acute Bacterial Infection
NCT ID: NCT00210639
Last Updated: 2014-04-21
Study Results
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View full resultsBasic Information
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COMPLETED
2233 participants
OBSERVATIONAL
2002-08-31
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Levofloxacin-treated cohort
Participants receiveing levofloxacin in previous levofloxacin studies will be observed.
No intervention
This is an observational study. Participants rceiving dosing regimen from the respective Phase 3 levofloxacin clinical studies will be observed in this study.
Comparator-treated cohort
Participants receiveing comparator in previous levofloxacin studies will be observed.
No intervention
This is an observational study. Participants rceiving dosing regimen from the respective Phase 3 levofloxacin clinical studies will be observed in this study.
Interventions
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No intervention
This is an observational study. Participants rceiving dosing regimen from the respective Phase 3 levofloxacin clinical studies will be observed in this study.
Eligibility Criteria
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Inclusion Criteria
* Parent or legal guardian read and signed the informed consent form
Exclusion Criteria
6 Months
16 Years
ALL
No
Sponsors
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
INDUSTRY
Responsible Party
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Principal Investigators
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Johnson & Johnson Pharmaceutical Research and Development, L.L .C.Clinical Trial
Role: STUDY_DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Locations
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Hoover, Alabama, United States
Mobile, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Madera, California, United States
Oakland, California, United States
Orange, California, United States
Paramount, California, United States
San Luis Obispo, California, United States
West Covina, California, United States
Centennial, Colorado, United States
Denver, Colorado, United States
Chiefland, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Blue Ridge, Georgia, United States
Marietta, Georgia, United States
‘Aiea, Hawaii, United States
Boise, Idaho, United States
Nampa, Idaho, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Bardstown, Kentucky, United States
Louisville, Kentucky, United States
Metairie, Louisiana, United States
New Orleans, Louisiana, United States
Shreveport, Louisiana, United States
Slidell, Louisiana, United States
Detroit, Michigan, United States
Royal Oak, Michigan, United States
Stevensville, Michigan, United States
Omaha, Nebraska, United States
Johnson City, New York, United States
Mineola, New York, United States
New York, New York, United States
Rochester, New York, United States
Akron, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Corpus Christi, Texas, United States
Houston, Texas, United States
Seguin, Texas, United States
Burke, Virginia, United States
Vienna, Virginia, United States
Buenos Aires, , Argentina
Loma Hermosa, , Argentina
San Isidro, , Argentina
Curitiba, , Brazil
Porto Alegre, , Brazil
São Paulo, , Brazil
Santiago, , Chile
Costa Rica, , Costa Rica
San José, , Costa Rica
Beersheba, , Israel
Guadalajara, , Mexico
Puebla City, , Mexico
Toluca, , Mexico
Zapopan, , Mexico
Zona, , Panama
Countries
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References
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Noel GJ, Bradley JS, Kauffman RE, Duffy CM, Gerbino PG, Arguedas A, Bagchi P, Balis DA, Blumer JL. Comparative safety profile of levofloxacin in 2523 children with a focus on four specific musculoskeletal disorders. Pediatr Infect Dis J. 2007 Oct;26(10):879-91. doi: 10.1097/INF.0b013e3180cbd382.
Bradley JS, Kauffman RE, Balis DA, Duffy CM, Gerbino PG, Maldonado SD, Noel GJ. Assessment of musculoskeletal toxicity 5 years after therapy with levofloxacin. Pediatrics. 2014 Jul;134(1):e146-53. doi: 10.1542/peds.2013-3636. Epub 2014 Jun 2.
Related Links
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A long-term study of the incidence of musculoskeletal disorders in children who have received levofloxacin or a standard non-fluoroquinolone therapy for acute bacterial infection
Other Identifiers
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LOFBO-LTSS-001
Identifier Type: OTHER
Identifier Source: secondary_id
PRI/LOF-INT-4
Identifier Type: OTHER
Identifier Source: secondary_id
CR004171
Identifier Type: -
Identifier Source: org_study_id
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